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510(k) Data Aggregation

    K Number
    K060531
    Device Name
    QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS
    Manufacturer
    SUNRISE MEDICAL
    Date Cleared
    2006-03-17

    (17 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quickie Rhythm & Groove Series Power Wheelchairs with Quickie/Delphi Controls intended use is to empower physically challenged individuals by providing a means of mobility.

    Device Description

    Not Found

    AI/ML Overview

    This is a notification from the FDA regarding a 510(k) premarket notification for "QuickieRhythm & Groove Scries Power Wheelchairs with Ouickie/Delphi Controls". This document is a regulatory approval, not a technical study report for an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.

    The document confirms that this device is a powered wheelchair, not an AI/ML diagnostic or prognostic device that would typically involve acceptance criteria and a study to prove performance as described in your request. The FDA's determination is based on the device being "substantially equivalent" to legally marketed predicate devices, not on a detailed analysis of performance against specific acceptance criteria for AI algorithms.

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